Sinemet CR

PATIENT INFORMATION

The patient should be informed that SINEMET CR is a
sustained-release formulation of carbidopa levodopa which releases these
ingredients over a 4- to 6-hour period. It is important that SINEMET CR be taken
at regular intervals according to the schedule outlined by the physician. The
patient should be cautioned not to change the prescribed dosage regimen and not
to add any additional antiparkinson medications, including other carbidopa
levodopa preparations, without first consulting the physician.

If abnormal involuntary movements appear or get worse
during treatment with SINEMET CR, the physician should be notified, as dosage
adjustment may be necessary.

Patients should be advised that sometimes the onset of
effect of the first morning dose of SINEMET CR may be delayed for up to 1 hour
compared with the response usually obtained from the first morning dose of
SINEMET. The physician should be notified if such delayed responses pose a
problem in treatment.

Patients should be advised that, occasionally, dark color
(red, brown, or black) may appear in saliva, urine, or sweat after ingestion of
SINEMET CR. Although the color appears to be clinically insignificant, garments
may become discolored.

The patient should be informed that a change in diet to
foods that are high in protein may delay the absorption of levodopa and may
reduce the amount taken up in the circulation. Excessive acidity also delays
stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as
in multivitamin tablets) may also reduce the amount of levodopa available to
the body. The above factors may reduce the clinical effectiveness of the
levodopa or carbidopa levodopa therapy.

Patients must be advised that the whole or half tablet
should be swallowed without chewing or crushing.

Patients should be alerted to the possibility of sudden
onset of sleep during daily activities, in some cases without awareness or
warning signs, when they are taking dopaminergic agents, including levodopa.
Patients should be advised to exercise caution while driving or operating
machinery and that if they have experienced somnolence and/or sudden sleep
onset, they must refrain from these activities. (See WARNINGS, Falling
Asleep During Activities of Daily Living and Somnolence.)

There have been reports of patients experiencing intense
urges to gamble, increased sexual urges, and other intense urges, and the
inability to control these urges while taking one or more of the medications
that increase central dopaminergic tone and that are generally used for the
treatment of Parkinson's disease, including SINEMET CR. Although it is not
proven that the medications caused these events, these urges were reported to
have stopped in some cases when the dose was reduced or the medication was
stopped. Prescribers should ask patients about the development of new or
increased gambling urges, sexual urges or other urges while being treated with
SINEMET CR. Patients should inform their physician if they experience new or
increased gambling urges, increased sexual urges, or other intense urges while
taking SINEMET CR. Physicians should consider dose reduction or stopping the medication
if a patient develops such urges while taking SINEMET CR. (See PRECAUTIONS,
Impulse Control / Compulsive Behaviors).

Last reviewed on RxList: 7/31/2014
This monograph has been modified to include the generic and brand name in many instances.